CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Nebivolol +5 moredrug
Likely dose
Nebivolol 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01595516
NCT01595516Phase 4Completed

Nebivolol and Endothelial Regulation of Fibrinolysis

University of Colorado, Boulder·interventional·Posted May 10, 2012·Updated Jun 25, 2019

In Brief

A Phase 4 clinical trial evaluating Nebivolol, Metoprolol, and 4 other interventions for Prehypertension and Hypertension. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartFeb 1, 2012
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.1 years ago

Interventions

Nebivololdrug

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprololdrug

100 mg tablet to be taken by mouth once per day for 12 weeks

Placebodrug

Gelatin capsule to be taken by mouth once per day for 12 weeks

Bradykininother

Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.

Salineother

Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.

Vitamin Cother

The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (\~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.